Cleared Traditional

Esophageal Stent System (K172813) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172813 · Micro-Tech (Nanjing) Co., Ltd. · Gastroenterology & Urology device
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May 2018
Decision
242d
Days
Class 2
Risk

K172813 is an FDA 510(k) clearance for the Esophageal Stent System. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on May 18, 2018 after a review of 242 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3610 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Micro-Tech (Nanjing) Co., Ltd. devices

Submission Details

510(k) Number K172813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2017
Decision Date May 18, 2018
Days to Decision 242 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 130d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ESW Prosthesis, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3610
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - ESW Prosthesis, Esophageal

All 32
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K172813.
HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
K200860 · M.I. Tech Co., Ltd. · May 2020
Segmented Esophageal Stent System
K182910 · Micro-Tech (Nanjing) Co., Ltd. · May 2019
Agile Esophageal Stent System
K180144 · Boston Scientific Corporation · Sep 2018
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K130004 · Boston Scientific Corporation · Dec 2013
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K120983 · Boston Scientific Corporation · May 2012
ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
K111611 · Merit Medical Systems, Inc. · Jul 2011